A Double-blind, Placebo-controlled Study of Levetiracetam in Epilepsy Patients With Generalized Tonic-clonic Seizures (Except Partial Seizures Evolving to Secondarily Generalized Seizures)
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| ClinicalTrials.gov Identifier: NCT01228747 |
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Recruitment Status :
Completed
First Posted : October 26, 2010
Results First Posted : May 13, 2015
Last Update Posted : January 15, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Epilepsy Generalized Tonic-Clonic Seizures | Drug: Levetiracetam Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 361 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Double-blind, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Treatment With Oral Levetiracetam, in Epilepsy Patients Aged ≥16 Years, With Generalized Tonic-clonic (GTC) Seizures |
| Study Start Date : | October 2010 |
| Actual Primary Completion Date : | April 2014 |
| Actual Study Completion Date : | May 2014 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Matching placebo for 28 weeks
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Drug: Placebo
Matching oral placebo tablets twice daily for 28 weeks |
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Experimental: Levetiracetam
Levetiracetam treatment with flexible dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks
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Drug: Levetiracetam
Oral dose at flexible increase doses: 1000 mg/day or 2000 mg/day or 3000 mg/day, twice daily, 28 weeks
Other Name: Keppra® |
- Percentage Change From the Combined Baseline in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 28-week Treatment Period (Dose Adjustment + Evaluation Periods) [ Time Frame: From Baseline to Week 28 ]
Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from Combined Baseline B over the Treatment Period A is calculated using the equation:
Percentage change from Baseline = ((A-B)/B)*100. Percentage change from baseline is not defined for subjects whose baseline information is missing / unknown or equal to zero, or whose seizure frequency per week is missing / unknown. A negative value in change in generalized tonic-clonic (GTC) seizure frequency indicates a reduction of generalized tonic-clonic (GTC) seizure frequency over the 28-week treatment Period.
Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline
- The Percentage Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Over the Evaluation Period [ Time Frame: From Baseline to Evaluation Period (Week 12 to Week 28) ]
Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from combined baseline B over the Evaluation Period A is calculated using the equation:
Percentage change from Baseline = ((A-B)/B)*100. Percentage change from baseline is not defined for subjects whose baseline Information is missing / unknown or equal to zero, or whose seizure frequency per week is missing / unknown. A negative value in change in generalized tonic-clonic (GTC) seizure frequency indicates a reduction of generalized tonic-clonic (GTC) seizure frequency.
Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline.
- Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period [ Time Frame: From Baseline to Week 28 ]
A subject with an at least 50 % reduction in weekly generalized tonic-clonic (GTC) seizure frequency from Combined Baseline Period to the Treatment Period is considered a GTC 50 % responder.
Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline
- Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Evaluation Period [ Time Frame: From Baseline to Evaluation Period (Week 12 to Week 28) ]
A subject with an at least 50 % reduction in weekly generalized tonic-clonic (GTC) seizure frequency from Combined Baseline Period to the Evaluation Period is considered a GTC 50 % responder.
Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline
- Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period [ Time Frame: Evaluation Period (Week 12 to Week 28) ]A subject with a non-missing weekly generalized tonic-clonic (GTC) baseline seizure frequency and a weekly GTC seizure frequency of zero throughout the Evaluation Period, is considered as a GTC seizure-free subject on the Evaluation Period.
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| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- An epilepsy patient with generalized tonic-clonic seizures that are classifiable according to the ILAE classification of epileptic seizures (Epilepsia, 1981)
- A patient on a stable dose of 1 or 2 anti-epileptic drugs for the last 4 weeks (potassium bromide and sodium bromide for the last 12 weeks) prior to and during the combined baseline period
Exclusion Criteria:
- Presence of any sign (clinical or imaging procedures) suggesting a progressive brain lesion/disease, in particular, progressive disorder with epileptic seizures
- Diagnosis of Lennox-Gastaut Syndrome
- Confirmed focal epilepsy based on clinical signs (seizure types), with consistent electroencephalogram and magnetic resonance imagining features
- A history of convulsive or non-convulsive status epilepticus while taking concomitant anti-epileptic drugs for the last 3 months prior to Visit 1
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01228747
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| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
Publications of Results:
| Responsible Party: | UCB Japan Co. Ltd. |
| ClinicalTrials.gov Identifier: | NCT01228747 |
| Other Study ID Numbers: |
N01159 2014-004401-32 ( EudraCT Number ) |
| First Posted: | October 26, 2010 Key Record Dates |
| Results First Posted: | May 13, 2015 |
| Last Update Posted: | January 15, 2019 |
| Last Verified: | December 2018 |
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Levetiracetam epilepsy generalized tonic-clonic |
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Epilepsy Seizures Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Neurologic Manifestations Levetiracetam Anticonvulsants Nootropic Agents |